Modification in Cortical Activation in Pseudophakic Patients With Visual Difficulties After a Multifocal Implantation

NCT02529098 | Withdrawn

• 1 other identifier: 12 523 03
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will highlight differences in cortical activation between asymptomatic and symptomatic patients.

Conditions

Vision Disorders

Keywords

functional magnetic resonance imaging; Lens implantation; pseudophakia

Outcome Measures

Primary Outcomes (1)

• Extent of neural activation in visual cortex measured by the number of voxels

  compare the extent of neural activation in visual cortex between groups

  1 day

Secondary Outcomes (1)

• extent of neural activation in visual cortex measured by the number of voxels

  1 day

Study Arms (2)

asymptomatic patients

SHAM COMPARATOR

fMRI Asymptomatic patients

Other: fMRI

symptomatic patients

EXPERIMENTAL

fMRI patients with visual difficulties

Other: fMRI

Interventions

fMRI OTHER

functional magnetic resonance imaging

asymptomatic patients; symptomatic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cataract surgery with an bilateral multifocal lens implant Restor
• Symptomatic patients :
• Symptomatic bilateral visual difficulties for 3 months or more after the intervention which impact the daily activity
• Asymptomatic patients :
• No visual complaint for 3 months or more after the intervention

You may not qualify if:

• Patients with ophthalmology disorders
• Contra indication for fMRI

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

UHToulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Vision Disorders; Pseudophakia

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Francois Malecaze, professor

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: August 19, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: June 1, 2016

Record last verified: 2016-05

Locations

FR (1)